Use of an Automated Surgical Impactor Reduces Femoral Broaching Time in Direct Anterior Approach Total Hip Arthroplasty: Results From a Randomized, Multicenter Study

木槌 拉削 医学 撞击 外科 随机对照试验 全髋关节置换术 关节置换术 髋关节置换术 工程类 机械工程 考古 历史
作者
Henry Clayton Thomason,John M. Redmond,J. Craig Morrison,David Fawley,Thierry Bernard,Brian P. Gladnick
出处
期刊:Arthroplasty today [Elsevier]
卷期号:28: 101480-101480
标识
DOI:10.1016/j.artd.2024.101480
摘要

BackgroundImpaction in total hip arthroplasty has typically been conducted using a mallet. A surgical automated impactor has been developed with the goal of reducing surgeon variability, fatigue, and injury. There is also potential to reduce the variability of each impaction step in which automated impaction is used, through reproducible and consistent application of force.MethodsPatients were randomized into either the mallet control group, or the automated impaction study group (1:1 randomization). The primary endpoint analysis was conducted to demonstrate that femoral broaching time (in minutes) with an automated impactor is noninferior to femoral broaching time with manual instruments (mallet) under a noninferiority (NI) margin of 1.25 minutes, with a subsequent test of superiority. A total of 218 patients were randomized and treated (109 in each group).ResultsMean femoral broaching time was 5.8 minutes in the automated impaction study group (automated), and 8.1 minutes in the mallet control group (mallet), a 28.4% reduction (P = .0005). However, there was not a difference in surgery duration between the groups. Three fractures were reported in the mallet group and 1 in the automated group.ConclusionsIn this randomized multicenter study, an automated impactor was shown to reduce femoral broaching time in primary total hip arthroplasty, with no increase in fractures, but no decrease in operating room time was noted.
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